Why it was recalled
cGMP deviations: Discolored acetaminophen
Product description
Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10
Lot numbers, UPCs & expiration codes
Lot #: S210240, Exp. 03/2023
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0729-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 16, 2021
- FDA report date
- Aug 25, 2021
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Spirit Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0729-2021, exactly as published.
Show all FDA fields
- City
- Ronkonkoma
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 88322
- Address
- 2004 Orville Dr N Ste 2
- Code information
- Lot #: S210240, Exp. 03/2023
- Postal code
- 11779-7645
- Report date
- Aug 25, 2021
- Product type
- Drugs
- Recall number
- D-0729-2021
- Classification
- Class II
- Recalling firm
- Spirit Pharmaceuticals
- Termination date
- Sep 7, 2022
- Reason for recall
- cGMP deviations: Discolored acetaminophen
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jun 16, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 16, 2021